It is to be one of most extensive studies ever undertaken into genetic susceptibility to disease. The Royal College of Surgeons (RCSI), in an alliance with the French genetics company Genset, is to attempt to identify genes that may predispose people to heart disease, the biggest cause of early death in Europe and a frequent cause of disability too.

It is the first time that a large clinical trial and genetic investigation has focused on heart disease, and will involve many thousands of patients. But it has genetic patenting implications.

There is a dispute over patient rights once commercial interests establish information about their genetic make-up.

Genset has been criticised in the past for the way it patents information; in particular, restrictions it placed on scientists seeking access to its data. However Prof Desmond Fitzgerald, chairman of the RSCI Clinical Pharmacology Department - which is playing a leading clinical role in the study - says there is no doubt that it is primarily in the patient's interest. It will lead to new information on how cardiovascular disease occurs and to new forms of treatment, he predicts.

A joint company called Surgen will bank DNA and blood samples in Dubin. It also aims to identify gene mutations which make people unresponsive to drugs, or lead to side effects when treating the disease.

Genset provides information on genes and mutations to drug companies. Through "gene discovery programmes", it focuses on the role of genes in conditions such as osteoporosis, heart disease and central nervous system diseases.

Its chairman and chief executive, Mr Pascal Brandy, has expressed delight at the prospect of combining "our next generation (gene) mapping technology with the extensive cardiovascular clinical research conducted by the RCSI."

RCSI is providing the ability to carry out studies with a large population base, and providing the clinical data necessary before any breakthrough is possible.

Prof Fitzgerald told The Irish Times that the clinicians involved from the RCSI end had "complete academic freedom to publish" any discovery or information they may find. "We are entirely happy that it is going to benefit patients and it is not overly commercial."

Medical records will be kept confidential and research data "anonymised" in clinical trials following US National Institutes of Health guidelines. Patients will be told of the study, including Genset's involvement, but not that their genetic information may be the subject of patenting.

"Normally, we don't give patients these details. That kind of information is not very useful to them."

On EU patenting regulations, he understood they related to research-derived "products" rather than genes. As for Genset, he said the company was "somewhat naive when it started out." A greater involvement of clinicians and academics now meant it was more aware of issues about which people are concerned.

Green MEP Ms Nuala Ahern is not convinced, however, that such trials give sufficient protection to patients. Earlier this month she wrote to the Minister for Health, Mr Cowen, seeking full details of the Surgen study, and underlined the concerns of patient representative groups.

She has sought information on how the genetic data will be accumulated and controlled, the issue of consent, and the Department's plans, if any, for an ethical review of such trials.

In the current climate, she believes, gene patenting favours multinational interests and that there is a lack of legislative protection of patients. "The Government must reject the second reading of the patenting directive in the European Parliament, and vote against it."

The RSCI, nonetheless, is gearing up for the Surgen project with an initial outlay of £1.6 million for laboratory facilities and equipment. Running costs, where Genset comes in, are expected to be $5 million over four years.

Prof Fitzgerald expects that through Surgen new forms of heart disease treatment will emerge within five to 10 years.